Clindamycin Phosphate and Benzoyl Peroxide

Product NDC: 0378-8688
Requested package NDC: 0378-8688-54
11-digit product format: 003788688
Labeler code: 0378
Product ID: 0378-8688_7ab087d0-276c-4b45-9685-9e6dc5ea1920
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: clindamycin phosphate and benzoyl peroxide
Dosage form: KIT
Labeler: Mylan Pharmaceuticals Inc.
Application: ANDA065443
Marketing category: ANDA
Marketing start: 2014-09-19
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A065443-001	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE	5%;EQ 1% BASE	GEL / TOPICAL	AB		2009-08-11

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A065443-001	AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A065443-001	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	5%;EQ 1% BASE	GEL / TOPICAL	AB	2009-08-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065443-001	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	5%;EQ 1% BASE	GEL / TOPICAL	AB	2009-08-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065443-001	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	5%;EQ 1% BASE	GEL / TOPICAL	AB	2009-08-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065443-001	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	5%;EQ 1% BASE	GEL / TOPICAL	AB	2009-08-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065443-001	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	5%;EQ 1% BASE	GEL / TOPICAL	AB	2009-08-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065443-001	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	5%;EQ 1% BASE	GEL / TOPICAL	AB	2009-08-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065443-001	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	5%;EQ 1% BASE	GEL / TOPICAL	AB	2009-08-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065443-001	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	5%;EQ 1% BASE	GEL / TOPICAL	AB	2009-08-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065443-001	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	5%;EQ 1% BASE	GEL / TOPICAL	AB	2009-08-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065443-001	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	5%;EQ 1% BASE	GEL / TOPICAL	AB	2009-08-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065443-001	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	5%;EQ 1% BASE	GEL / TOPICAL	AB	2009-08-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065443-001	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	5%;EQ 1% BASE	GEL / TOPICAL	AB	2009-08-11	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065443-001	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	5%;EQ 1% BASE	GEL / TOPICAL	AB	2009-08-11	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065443-001	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	5%;EQ 1% BASE	GEL / TOPICAL	AB	2009-08-11	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065443-001	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	5%;EQ 1% BASE	GEL / TOPICAL	AB	2009-08-11	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065443-001	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	5%;EQ 1% BASE	GEL / TOPICAL	AB	2009-08-11	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065443-001	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	5%;EQ 1% BASE	GEL / TOPICAL	AB	2009-08-11	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065443-001	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	5%;EQ 1% BASE	GEL / TOPICAL	AB	2009-08-11	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065443-001	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	5%;EQ 1% BASE	GEL / TOPICAL	AB	2009-08-11	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065443-001	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	5%;EQ 1% BASE	GEL / TOPICAL	AB	2009-08-11	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A065443-001	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	5%;EQ 1% BASE	GEL / TOPICAL	AB	2009-08-11	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A065443-001	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	5%;EQ 1% BASE	GEL / TOPICAL	AB	2009-08-11	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A065443-001	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	5%;EQ 1% BASE	GEL / TOPICAL	AB	2009-08-11	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A065443-001	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	5%;EQ 1% BASE	GEL / TOPICAL	AB	2009-08-11	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A065443-001	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	5%;EQ 1% BASE	GEL / TOPICAL	AB	2009-08-11	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A065443-001	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	5%;EQ 1% BASE	GEL / TOPICAL	AB	2009-08-11	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A065443-001	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	5%;EQ 1% BASE	GEL / TOPICAL	AB	2009-08-11	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A065443-001	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	5%;EQ 1% BASE	GEL / TOPICAL	AB	2009-08-11	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A065443-001	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	5%;EQ 1% BASE	GEL / TOPICAL	AB	2009-08-11	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A065443-001	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	5%;EQ 1% BASE	GEL / TOPICAL	AB	2009-08-11	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A065443-001	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	5%;EQ 1% BASE	GEL / TOPICAL	AB	2009-08-11	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A065443-001	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	5%;EQ 1% BASE	GEL / TOPICAL	AB	2009-08-11	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A065443-001	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	5%;EQ 1% BASE	GEL / TOPICAL	AB	2009-08-11	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A065443-001	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	5%;EQ 1% BASE	GEL / TOPICAL	AB	2009-08-11	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A065443-001	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	5%;EQ 1% BASE	GEL / TOPICAL	AB	2009-08-11	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A065443-001	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	5%;EQ 1% BASE	GEL / TOPICAL	AB	2009-08-11	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A065443-001	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	5%;EQ 1% BASE	GEL / TOPICAL	AB	2009-08-11	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A065443-001	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	5%;EQ 1% BASE	GEL / TOPICAL	AB	2009-08-11	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A065443-001	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	5%;EQ 1% BASE	GEL / TOPICAL	AB	2009-08-11	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A065443-001	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	5%;EQ 1% BASE	GEL / TOPICAL	AB	2009-08-11	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A065443-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065443-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065443-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065443-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065443-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065443-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065443-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065443-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065443-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065443-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065443-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065443-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065443-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065443-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065443-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065443-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065443-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065443-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065443-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065443-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A065443-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A065443-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A065443-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A065443-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A065443-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A065443-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A065443-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A065443-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A065443-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A065443-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A065443-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A065443-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A065443-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A065443-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A065443-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A065443-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A065443-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A065443-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A065443-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A065443-001	AB	1	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: Clindamycin Phosphate and Benzoyl Peroxide
Listing expiration: 2026-12-31

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
308689	Internal RxNorm lookup
358917	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
96b3e35a-e174-49cd-8695-acd7d23e7710	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
a46239a7-5963-4008-8cbb-6b9000f497eb	Product name	1	20250721
1426d8f8-b7d5-4053-8554-613df00c0d86	Product name	2	20250616
b382b4e1-6b48-45f6-bffc-e61b00b0ce19	Product name	3	20250317
d8f81258-db12-0761-46cc-8ff6e62e9302	Product name	4	20240422
b7b2fa42-1c77-d724-81f0-87da60a77e79	Product name	3	20240320
b27c7c65-51f2-a62f-e0e6-a26b3a0f8eb0	Product name	3	20230425
d9d61457-6a5a-41fc-b418-e5479a2904b7	Product name	2	20230303
32012d5c-25ac-49c7-9d4c-1313177fff7c	Product name	1	20230112
e3af9708-3004-7392-4046-5311eaa8bab5	Product name	3	20221128
ffb4bacf-f636-0f7d-0b0d-7a4b151243e3	Product name	9	20220928
b72227d6-0388-43bd-995b-b762d2754cd5	Product name	1	20220706
a92d22e0-3af4-f301-bc88-27ff030b0070	Product name	2	20220316
13e7e7e3-e885-4c79-af6d-dad1aedbb06e	Product name	1	20220128
4a7d44fe-774d-404b-aad0-8a90fe78375a	Product name	4	20211025
3f45980c-c196-47e5-0e5e-48b7c57327c5	Product name	5	20200428
d12e2d7c-bd6b-45d4-94f9-6df8e1b8b27b	Product name	3	20200203
ee5c6de5-d9cd-454f-b250-7b19e5cf2992	Product name	4	20190619
5ce6ce33-4f2b-3ce0-757d-e520013280cf	Product name	5	20180719
ad75fcfd-a339-42a1-9c60-43ba2c654cfa	Product name	1	20170810
b92a26f1-6926-4817-be73-e26ab4c2146f	Product name	1	20170602
028d6c95-5012-6976-2075-dee0ae6fefe2	Product name	1	20140508
468b2c08-8adb-8d0f-8257-c6515a061424	Product name	1	20140508
8959fb29-d86f-c521-666a-b4cb22233594	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0378-8688-35	Clindamycin Phosphate and Benzoyl Peroxide	1 in 1 CARTON	KIT	1		16
0378-8688-54	Clindamycin Phosphate and Benzoyl Peroxide	1 in 1 CARTON	KIT	1		3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0378-8688-35	GM - Gram	0378-8688	61859794-69db-4dde-9cc7-da7a474b4693	1	2013-02-13
0378-8688-50	GM - Gram	0378-8688	bce222a2-f1af-44b8-bc7b-5cc9d5a6869c	1	2019-05-02
0378-8688-52	GM - Gram	0378-8688	a18d186d-6f5c-496f-8365-1f87fd71bb93	1	2019-05-02
0378-8688-54	GM - Gram	0378-8688	220f7bc3-9d66-44b4-af0f-f3e7464d65c7	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
BENZOYL PEROXIDE	ACTIVE INGREDIENT	W9WZN9A0GM	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE KIT [MYLAN PHARMACEUTICALS INC.]	6
CLINDAMYCIN PHOSPHATE	ACTIVE INGREDIENT	EH6D7113I8	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE KIT [MYLAN PHARMACEUTICALS INC.]	6
BENZOYL PEROXIDE	ACTIVE MOIETY	W9WZN9A0GM	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE KIT [MYLAN PHARMACEUTICALS INC.]	6
CLINDAMYCIN	ACTIVE MOIETY	3U02EL437C	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE KIT [MYLAN PHARMACEUTICALS INC.]	6
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)	INACTIVE INGREDIENT	4Q93RCW27E	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE KIT [MYLAN PHARMACEUTICALS INC.]	6
POTASSIUM HYDROXIDE	INACTIVE INGREDIENT	WZH3C48M4T	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE KIT [MYLAN PHARMACEUTICALS INC.]	6
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE KIT [MYLAN PHARMACEUTICALS INC.]	6
WATER	INACTIVE INGREDIENT	059QF0KO0R	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE KIT [MYLAN PHARMACEUTICALS INC.]	6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0378-8688	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE KIT [MYLAN PHARMACEUTICALS INC.]	16	Current NDC, Legacy NDC, 1 package rows	20241218_96b3e35a-e174-49cd-8695-acd7d23e7710.zip
0378-8688	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE KIT [MYLAN PHARMACEUTICALS INC.]	3	Current NDC, Legacy NDC, 1 package rows	20241215_0e98ee9b-84e9-4cd8-a3ea-1247e1a510a5.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Clindamycin Phosphate and Benzoyl Peroxide	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	Mylan Pharmaceuticals Inc.	96b3e35a-e174-49cd-8695-acd7d23e7710	2024-10-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065443 application number: ANDA065443 ndc (product): 0378-8688
Clindamycin Phosphate and Benzoyl Peroxide	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	Mylan Pharmaceuticals Inc.	0e98ee9b-84e9-4cd8-a3ea-1247e1a510a5	2024-10-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065443 application number: ANDA065443 ndc (package): 0378-8688-54 ndc (product): 0378-8688 ndc11 (package): 00378868854

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
308689	benzoyl peroxide 2.5 % Topical Gel	PSN	96b3e35a-e174-49cd-8695-acd7d23e7710	16
358917	clindamycin phosphate 1 % / benzoyl peroxide 5 % Topical Gel	PSN	96b3e35a-e174-49cd-8695-acd7d23e7710	16
308689	benzoyl peroxide 0.025 MG/MG Topical Gel	SCD	96b3e35a-e174-49cd-8695-acd7d23e7710	16
358917	benzoyl peroxide 0.05 MG/MG / clindamycin 0.01 MG/MG Topical Gel	SCD	96b3e35a-e174-49cd-8695-acd7d23e7710	16
308689	benzoyl peroxide 2.5 % Topical Gel	SY	96b3e35a-e174-49cd-8695-acd7d23e7710	16
358917	benzoyl peroxide 5 % / clindamycin 1 % (as clindamycin phosphate 1.2 % ) Topical Gel	SY	96b3e35a-e174-49cd-8695-acd7d23e7710	16
358917	benzoyl peroxide 5 % / clindamycin 1 % Topical Gel	SY	96b3e35a-e174-49cd-8695-acd7d23e7710	16
308694	benzoyl peroxide 5 % Topical Gel	PSN	0e98ee9b-84e9-4cd8-a3ea-1247e1a510a5	3
358917	clindamycin phosphate 1 % / benzoyl peroxide 5 % Topical Gel	PSN	0e98ee9b-84e9-4cd8-a3ea-1247e1a510a5	3
309333	clindamycin phosphate 1 % Topical Solution	PSN	0e98ee9b-84e9-4cd8-a3ea-1247e1a510a5	3
358917	benzoyl peroxide 0.05 MG/MG / clindamycin 0.01 MG/MG Topical Gel	SCD	0e98ee9b-84e9-4cd8-a3ea-1247e1a510a5	3
308694	benzoyl peroxide 0.05 MG/MG Topical Gel	SCD	0e98ee9b-84e9-4cd8-a3ea-1247e1a510a5	3
309333	clindamycin 10 MG/ML Topical Solution	SCD	0e98ee9b-84e9-4cd8-a3ea-1247e1a510a5	3
358917	benzoyl peroxide 5 % / clindamycin 1 % (as clindamycin phosphate 1.2 % ) Topical Gel	SY	0e98ee9b-84e9-4cd8-a3ea-1247e1a510a5	3
358917	benzoyl peroxide 5 % / clindamycin 1 % Topical Gel	SY	0e98ee9b-84e9-4cd8-a3ea-1247e1a510a5	3
308694	benzoyl peroxide 5 % Topical Gel	SY	0e98ee9b-84e9-4cd8-a3ea-1247e1a510a5	3
309333	clindamycin (as clindamycin phosphate) 1 % Topical Solution	SY	0e98ee9b-84e9-4cd8-a3ea-1247e1a510a5	3
309333	clindamycin 1 % Topical Solution	SY	0e98ee9b-84e9-4cd8-a3ea-1247e1a510a5	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0378-8688-54	00378868854	1 KIT in 1 CARTON (0378-8688-54) * 10 g in 1 BOTTLE, PLASTIC * 40 g in 1 JAR	1 kit	2009-08-25	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Clindamycin Phosphate and Benzoyl Peroxide - Mylan Pharmaceuticals Inc.	Mylan Pharmaceuticals Inc.	2024-10-15	HUMAN PRESCRIPTION DRUG LABEL	16
Clindamycin Phosphate and Benzoyl Peroxide - Mylan Pharmaceuticals Inc.	Mylan Pharmaceuticals Inc.	2024-10-15	HUMAN PRESCRIPTION DRUG LABEL	3
Clindamycin Phosphate and Benzoyl Peroxide - Mylan Pharmaceuticals Inc.	Mylan Pharmaceuticals Inc.	2018-09-27	HUMAN PRESCRIPTION DRUG LABEL	2
Clindamycin Phosphate and Benzoyl Peroxide - Mylan Pharmaceuticals Inc.	Mylan Pharmaceuticals Inc.	2018-09-27	HUMAN PRESCRIPTION DRUG LABEL	2